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Dizal Pharmaceutical’s Surufatinib Earns CDE Consideration for Breakthrough Therapy in EGFR exon20ins NSCLC
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Dizal Pharmaceutical, a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) in China is considering its drug candidate DZD9008 for breakthrough therapy status. The drug is designed to treat patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not received…
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Hengrui Pharmaceuticals’ HR19042 Capsules Designated as Breakthrough Therapy for Autoimmune Hepatitis by China NMPA
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The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has recently announced that Hengrui Pharmaceuticals (SHA: 600276)’s Class 2.2 improved drug, HR19042 capsule, is planned to be included in the breakthrough therapy category, targeting active autoimmune hepatitis. According to previous announcements by Hengrui Pharmaceuticals, HR19042 is…
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NMPA Clears AbbVie’s ABBV-706 for Clinical Trials Targeting SCLC and Neuroendocrine Tumors
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The China National Medical Products Administration (NMPA) has granted clinical trial approval to ABBV-706, a novel antibody-drug conjugate (ADC) developed by AbbVie (NYSE: ABBV), for the treatment of relapsed/refractory small cell lung cancer (SCLC) and other neuroendocrine tumors . ABBV-706 is a targeted therapy that binds to SEZ6, a protein…
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Jiangsu Alphamab Biopharmaceuticals Partners with Shanghai Jinmant Biotech for JSKN003 ADC
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has announced that its wholly-owned subsidiary, Jiangsu Alphamab Biopharmaceuticals Co. Ltd, has entered into a licensing agreement with Shanghai Jinmant Biotech Co., Ltd, a subsidiary of CSPC Pharmaceutical Group Co., Ltd (HKG: 1093), for the development and commercialization of its…
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CStone Pharmaceuticals’ Partner HengRui Medicine Launches Phase III Trial for CTLA-4 Antibody in HCC
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CStone Pharmaceuticals (HKG: 2616), an innovation-driven biopharmaceutical company focused on the development of oncology drugs, announced today that its partner, HengRui Medicine, has initiated a Phase III clinical study for CS1002/SHR-8068 (an anti-CTLA-4 monoclonal antibody) in combination with adebrelimab and bevacizumab for the first-line treatment of advanced hepatocellular carcinoma (HCC).…
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Zephyrm Bioscience Aims for HKEX Main Board with Innovative Cell Therapy Products
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Zephyrm Bioscience Limited (hereinafter referred to as “Zephyrm Bio”) officially submitted its prospectus to the Hong Kong Stock Exchange (HKEX) on September 30, 2024, with the intention to list on the Main Board, with CICC acting as the sole sponsor. Established in 2017, Zephyrm Bio, a clinical-stage biopharmaceutical company, is…
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Akeso Biopharma’s Cadonilimab Secures NMPA Approval for Gastric Cancer Indication
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Akeso Biopharma Inc. (HKG: 9926) announced that its self-developed PD-1/CTLA-4 bispecific antibody, Cadonilimab injection (AK104), has been approved by the National Medical Products Administration (NMPA) in China for a new indication. This is the second indication for the product in China and is for the first-line treatment of patients with…
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Alphamab Oncology Strikes Licensing Deal with CSPC Pharma for HER2 Targeted ADC in China
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Alphamab Oncology (HKG: 9966), a biopharmaceutical company based in China, has entered into a licensing agreement with fellow Chinese firm CSPC Pharmaceutical Group Ltd (HKG: 1093). The deal grants CSPC exclusive license and sub-license rights to Alphamab’s JSKN003 in mainland China for development, sales, and commercialization related to oncology indications.…
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Sichuan Biokin’s Partner Bristol-Myers Squibb Gets FDA Nod for Bispecific ADC Study
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a Chinese biopharmaceutical company, has announced that its U.S. partner Bristol-Myers Squibb has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I/IIa study for BL-B01D1, an in-house developed bispecific antibody drug conjugate (ADC), in patients with advanced…
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J&J’s Carvykti Shows 45% Reduced Risk of Death in Multiple Myeloma Patients, Landmark Trial Data Reveals
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Johnson & Johnson (J&J, NYSE: JNJ), a U.S.-based healthcare conglomerate, has released new clinical trial data for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Carvykti (ciltacabtagene autoleucel). The data reveals long-term overall survival (OS) for the therapy’s use as a second-line treatment for multiple myeloma (MM). The three-year…
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Yabao Pharmaceutical’s SY-009 Receives NMPA Approval for Phase II Clinical Trial in Constipation
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Yabao Pharmaceutical Group Co., Ltd (SHA: 600351), a Chinese pharmaceutical company, has announced that SY-009 capsules, a sodium-glucose linked transporter-1 (SGLT-1) inhibitor co-developed with Eli Lilly & Co., (NYSE: LLY) have received approval from the National Medical Products Administration (NMPA) to proceed to a Phase II clinical study for the…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Green Light for Clinical Trial of TSLP-Targeted Asthma Treatment
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 product SHR1905, a thymic stromal lymphopoietin (TSLP)-targeted monoclonal antibody (mAb). The product is…
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Bayer AG Launches New Life Sciences Incubator in Shanghai to Boost Biotech Ecosystem
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Bayer AG (ETR: BAYN, FRA: BAYN, OTCMKTS: BAYRY), a leading German life sciences company, announced last week the opening of a new life sciences incubator in Shanghai, named Bayer Co.Lab Shanghai. The incubator is located in the Shanghai Innovation (SH-INNO) Park within the Zhanghiang biopharma cluster and is part of…
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Huadong Medicine Gets NMPA Green Light for Clinical Trials of Roflumilast Cream
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received clinical trial approvals from the National Medical Products Administration (NMPA) for its Zoryve cream (roflumilast) in concentrations of 0.15% and 0.3%. These formulations are indicated for the treatment of mild to moderate atopic dermatitis…
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LenoMed Medical’s Touch-Insulin Pump Receives NMPA Approval, Aids China’s Diabetes Management
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Shanghai-based LenoMed Medical, a medical device platform company backed by Legend Capital and Legend Star, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its in-house developed touch-insulin pump. This product, which boasts an infusion accuracy of 0.01U per hour, is lauded as…
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Mindray Bio-Medical Partners with Nanjing Drum Tower Hospital to Boost Clinical Research
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Shenzhen Mindray Bio-Medical Electronics Co., Ltd (SHE: 300760), a leading medical equipment provider, has entered into a partnership with Nanjing Drum Tower Hospital, a prestigious and historically significant hospital in China. The collaboration will focus on key medical disciplines of the hospital and involve clinical study cooperation as part of…
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Qilu Pharmaceutical’s QL1706 Receives NMPA Conditional Approval for Cervical Cancer Treatment
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Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its combination drug QL1706, comprising iparomlimab and tuvonralimab, has received conditional marketing approval from the National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic cervical cancer. QL1706 (PSB205), originally developed by the U.S. biotech Qilu Puget Sound Biotherapeutic…
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Dupixent Secures Back-to-Back COPD Approvals from US FDA and China NMPA
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Regeneron (NASDAQ: REGN), a leading biopharmaceutical company based in the U.S., in collaboration with its French partner Sanofi (NSE: SANOFI), announced on September 27 that Dupixent (dupilumab) has received approvals for the treatment of chronic obstructive pulmonary disorder (COPD) from both the U.S. Food and Drug Administration (FDA) and China’s…
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AbbVie Submits First BLA for c-Met Targeting ADC Telisotuzumab Vedotin to FDA
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AbbVie Inc. (NYSE: ABBV), a leading pharmaceutical company in the U.S., has announced the filing of a first Biologics License Application (BLA) for telisotuzumab vedotin (Teliso-V), a first-in-class antibody-drug conjugate (ADC) targeting tumors that overexpress the c-Met protein. The U.S. Food and Drug Administration (FDA) has accepted the filing for…
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Whittilong Pharma Secures Over RMB 100 Million in Series B Financing for Modified Drug Development
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Whittilong Pharma, a Shanghai-based modified drug development company backed by Shanghai Healthcare Capital (SHC), has reportedly secured over RMB 100 million in a Series B financing round. The funding was provided by multiple family offices. Established in 2018, Whittilong Pharma specializes in the research and development of a diverse range…
